Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial
NCT ID: NCT06527547
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
52 participants
INTERVENTIONAL
2024-06-06
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Can taVNS improve the sleep quality of RA patients? What medical issues might RA patients experience while receiving taVNS treatment? Researchers will compare taVNS with a placebo (a similar substance that does not contain the actual treatment) to see if taVNS is effective in improving sleep disorders in RA patients.
Participants will:
Receive taVNS or sham stimulation daily for 4 weeks Keep a daily sleep diary and visit the hospital once a week for check-ups and tests Record their sleep quality and related symptoms This study aims to provide a new, safe, and effective non-drug therapy for sleep disorders related to RA.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Quality of Sleep in Patients With Rheumatoid Arthritis
NCT00287794
Effect of Home-Based Transcranial Direct Current Stimulation on Pain in Patients With Rheumatoid Arthritis With Low Inflammatory Activity
NCT07162311
Evaluation of the Effect of Acupuncture on Hand Pain, Functional Deficits and Health Related Quality of Life in Patients With Rheumatoid Arthritis
NCT02553005
Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis
NCT01919645
Vagus Nerve Stimulation in Rheumatoid Arthritis
NCT00859859
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
taVNS Group
This arm consists of 26 participants diagnosed with rheumatoid arthritis who will receive transcutaneous auricular vagus nerve stimulation (taVNS) using the Huatuo electronic acupuncture device (model SDZ-IIB). Participants will be trained by a qualified physician to correctly position the earpieces on the auricular points corresponding to the heart and kidney. Treatment will be conducted at home, with each participant undergoing stimulation twice daily for 30 minutes each session, over a period of 5 consecutive days each week. The total intervention duration will last for 4 weeks. The stimulation frequency will be set at 20 Hz, using a sparse-dense wave pattern, with the intensity adjusted to the maximum level tolerated by the patient without causing pain.
Transcutaneous Auricular Vagus Nerve Stimulation
Treatment using the Huatuo electronic acupuncture device (model SDZ-IIB) with electrodes placed on the auricular points related to the heart and kidney. Pulsed wave type is sparse-dense wave, with a frequency of 20Hz and intensity set to the highest level tolerable without pain. Patients will perform self-treatment at home for 30 minutes, twice daily, for 5 days a week over 4 weeks.
Sham Stimulation Group
This arm includes 26 participants with rheumatoid arthritis who will receive sham stimulation using the same Huatuo electronic acupuncture device (model SDZ-IIB). Participants will be instructed on how to properly use the device, which will involve special sham electrodes placed over different ear areas not corresponding to therapeutic points (on the ear helix, specifically over the clavicle and shoulder points). The sham treatment will follow the same schedule as the experimental group: stimulation twice daily for 30 minutes per session, for 5 consecutive days each week, over 4 weeks. The device will be set to the same frequency and intensity as the experimental group, simulating the feeling of stimulation without delivering effective therapeutic intervention.
Sham Stimulation
Treatment using the same Huatuo electronic acupuncture device with electrodes placed on different ear points (over the ear helix). The device settings (pulse type, frequency, intensity) are the same as the experimental group but do not correspond to traditional acupuncture points. Patients will also perform self-treatment at home as per the same schedule as the experimental group.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transcutaneous Auricular Vagus Nerve Stimulation
Treatment using the Huatuo electronic acupuncture device (model SDZ-IIB) with electrodes placed on the auricular points related to the heart and kidney. Pulsed wave type is sparse-dense wave, with a frequency of 20Hz and intensity set to the highest level tolerable without pain. Patients will perform self-treatment at home for 30 minutes, twice daily, for 5 days a week over 4 weeks.
Sham Stimulation
Treatment using the same Huatuo electronic acupuncture device with electrodes placed on different ear points (over the ear helix). The device settings (pulse type, frequency, intensity) are the same as the experimental group but do not correspond to traditional acupuncture points. Patients will also perform self-treatment at home as per the same schedule as the experimental group.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Poor sleep quality (PSQI score \> 7).
3. Disease activity is moderate to low or in remission (DAS28 score ≤ 5.1).
4. No risk of sleep apnea (STOP-Bang questionnaire \< 3).
5. Aged between 18 and 70.
6. The type and dosage of rheumatoid arthritis medication must be stable for at least 4 weeks.
7. Signed informed consent.
Exclusion Criteria
2. Those with severe internal organ diseases (such as coronary heart disease, arrhythmia, malignant tumors, renal failure, etc.);
3. Those working night shifts during the intervention period;
4. Those with other rheumatic diseases such as systemic lupus erythematosus, fibromyalgia, and Sjogren's syndrome;
5. Those undergoing treatment with steroids, sleeping pills, antidepressants, or antipsychotics;
6. Pregnant and breastfeeding women;
7. Those who cannot tolerate transcutaneous auricular electrostimulation.
18 Years
72 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hebei Provincial Hospital of Traditional Chinese Medicine
OTHER_GOV
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Shenzhen Futian Hospital of TCM
OTHER_GOV
Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
UNKNOWN
Juan Jiao
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Juan Jiao
professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guang'anmen Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CI2021B007
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-139-KY-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.